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Trial registered on ANZCTR


Registration number
ACTRN12624000807550
Ethics application status
Approved
Date submitted
14/06/2024
Date registered
29/06/2024
Date last updated
29/06/2024
Date data sharing statement initially provided
29/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Movement Treatment Following Rhizolysis
Scientific title
Does a movement-based self-management program improve outcomes for people with chronic low back pain following their lumbar facet procedures? A pilot randomised controlled trial
Secondary ID [1] 312275 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic back pain 333995 0
Facet joint rhizolysis 334176 0
Condition category
Condition code
Public Health 330665 330665 0 0
Health service research
Public Health 330666 330666 0 0
Health promotion/education
Physical Medicine / Rehabilitation 330843 330843 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are randomly allocated to the Movement is Medicine (MiM) intervention treatment will be booked to attend one of four groups of the 6-week treatment program (n~8 participants per group). The maximum total sample size is n=32 for this intervention. The four groups will run consecutively over a period of 8 months, with approximately 2 weeks' break between each group. The treatment participation will commence from 2 weeks and up to 12 weeks post-rhizolysis. The intervention will comprise 6 x 3hr small-group sessions (held once weekly), conducted face-to-face in a group room at Flinders Medical Centre Pain Unit clinic.

The intervention will include pain science education regarding movement and graded exercise, activity pacing, managing flare-ups, and guided demonstrations around breathing/relaxation, and low-intensity exercise (e.g. stretching, muscle relaxation, yoga), with exercise-based homework in-between sessions.
In the first and last sessions, participants will complete several simple tests of functional ability (including standing and walking speed, and functional reach), closely supervised by the physiotherapist facilitator, taking 5 minutes maximum. Participants in the intervention treatment receive a treatment manual with all study materials, space to record individualised treatment plans, and weekly homework tasks and progress review.

Two facilitators will be present at each intervention session to ensure participants remain engaged. Each facilitator will lead different sections of the session to maximize individual participant interaction. The primary facilitator is a registered physiotherapist, while the co-facilitator is a registered nurse. Facilitators record session attendance, and participants who do not attend are contacted by phone to determine the reason for their absence.

At commencement and completion of the treatment group, group facilitators will send courtesy letters to participants’ referring GP, as well as an email to the Pain Unit doctor who referred them to the research project, as a duty of care, and to provide continuity of care (done with participants’ explicit consent).

Immediately following completion of the intervention (MiM) program, participants will be made aware that they will be contacted again in three months for a check-in and follow-up.

Intervention participants are reimbursed up to $120 (depending on their session attendance).
Intervention code [1] 328741 0
Treatment: Other
Intervention code [2] 328881 0
Rehabilitation
Comparator / control treatment
Participants who are randomly allocated to the control condition will only participate in 'treatment as usual', i.e., having their rhizolysis procedure and attending their usual healthcare appointments and treatments both in the Pain Management Unit (differing by patient, but mostly involving medical reviews) and elsewhere. The maximum total sample size is n=32 for the control condition.

Control participants are informed that they are able to ask their Pain Unit doctor to refer them to the Movement is Medicine program (run within normal Pain Unit clinical practice, and not as research) after their study completion is finished, if they are still interested in taking part.

Control participants are reimbursed $50.
Control group
Active

Outcomes
Primary outcome [1] 338422 0
Physical function (completed by the intervention group only)
Timepoint [1] 338422 0
During the first Movement is Medicine treatment session (session 1); and during the last Movement is Medicine treatment session (session 6)
Primary outcome [2] 338423 0
Fear of movement
Timepoint [2] 338423 0
This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
Primary outcome [3] 338424 0
Lower back pain
Timepoint [3] 338424 0
This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
Secondary outcome [1] 435874 0
Pain Severity
Timepoint [1] 435874 0
This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
Secondary outcome [2] 435875 0
Pain Interference
Timepoint [2] 435875 0
This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
Secondary outcome [3] 435876 0
Pain self-efficacy
Timepoint [3] 435876 0
This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
Secondary outcome [4] 436394 0
Pain catastrophising
Timepoint [4] 436394 0
This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
Secondary outcome [5] 436420 0
recruitment rates (and reasons)
Timepoint [5] 436420 0
Assessed at the conclusion of the study period
Secondary outcome [6] 436421 0
Group attendance rates (intervention group only)
Timepoint [6] 436421 0
Assessed at the conclusion of the study period
Secondary outcome [7] 436422 0
Homework/therapy adherence (intervention group only)
Timepoint [7] 436422 0
Assessed at the conclusion of the study period
Secondary outcome [8] 436423 0
Participant satisfaction (intervention participants only)
Timepoint [8] 436423 0
During participants' last Movement is Medicine session
Secondary outcome [9] 436424 0
Patient pain management goals
Timepoint [9] 436424 0
Baseline, treatment end and 3-month follow-up (similarly-timed timepoints for control participants)
Secondary outcome [10] 436425 0
Subsequent rhizolysis procedures
Timepoint [10] 436425 0
12 months following participants' baseline rhizolysis procedure
Secondary outcome [11] 436630 0
Depression
Timepoint [11] 436630 0
This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
Secondary outcome [12] 436631 0
Anxiety
Timepoint [12] 436631 0
This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
Secondary outcome [13] 436632 0
Stress
Timepoint [13] 436632 0
This measure is assessed (1) The week prior to commencing Movement is Medicine treatment; (2) treatment mid-point i.e. after session 3 (control participants do not complete this timepoint); (3) treatment end-point; and (4) 3-month follow-up i.e. after treatment end-point. Control participants complete measures at similar timepoints to the intervention group.
Secondary outcome [14] 436633 0
Drop-out rates (and reasons)
Timepoint [14] 436633 0
Assessed at the conclusion of the study period

Eligibility
Key inclusion criteria
Existing Flinders Medical Centre Pain Management Unit patients who are booked to receive their first lumbar rhizolysis procedure at the Pain Unit.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have already had a lumbar rhizolysis procedure
Previously completed/are currently undergoing Flinders Pain Management Unit Allied Health group programs
Severe mobility issues
Issues with dizziness/balance
Actively suicidal
Unstable mental health
Requiring an interpreter
Significant cognitive impairment
Significant visual or auditory difficulties (which would be a major impediment to group participation)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/06/2024
Date of last participant enrolment
Anticipated
17/03/2025
Actual
Date of last data collection
Anticipated
24/03/2026
Actual
Sample size
Target
64
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26647 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 42687 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 316662 0
Charities/Societies/Foundations
Name [1] 316662 0
The Hospital Research Foundation (given to the SAHLN Enquiry grant round)
Country [1] 316662 0
Australia
Funding source category [2] 316743 0
Charities/Societies/Foundations
Name [2] 316743 0
The Flinders Foundation (given to the SALHN enquiry grant round)
Country [2] 316743 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 318874 0
Hospital
Name [1] 318874 0
The Flinders Medical Centre (Pain Management Unit. C/O Dr Amelia Searle)
Address [1] 318874 0
Country [1] 318874 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315442 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 315442 0
https://www.sahealth.sa.gov.au/wps/wcm/connect/Public%2BContent/SA%2BHealth%2BInternet/About%2Bus/Our%2BLocal%2BHealth%2BNetworks/Southern%2BAdelaide%2BLocal%2BHealth%2BNetwork/Research/For%2BResearchers/Southern%2BAdelaide%2BClinical%2BHuman%2BResearch%2BEthics%2BCommittee
Ethics committee country [1] 315442 0
Australia
Date submitted for ethics approval [1] 315442 0
19/01/2024
Approval date [1] 315442 0
04/04/2024
Ethics approval number [1] 315442 0

Summary
Brief summary
The aim of this study is determine the effectiveness and feasibility of implementing the Movement is Medicine (MiM) small-group program after patients undergo facet joint rhizolysis for their chronic back pain. Participants randomly allocated to the intervention condition attend one of four 6-week (18 hours total) Movement is Medicine small-group interventions following their rhizolysis procedure, with around 8 participants per group, and led by two trained facilitators. Sessions include pain science, relaxation/breathing, and guided demonstrations of various low-intensity exercise options, with all of these techniques suggested as homework between sessions. Control participants simply attend their usual healthcare appointments following their rhizolysis procedure. Outcome measures include functional assessments, as well as self-reported symptoms of pain intensity/interference, lower back pain disability, fear of movement, depression, anxiety and stress, pain self-efficacy, and pain catastrophising, completed immediately before and after the intervention, and three months later (and similar timepoints for controls). If the intervention improves self-management, functional outcomes and quality of life, these patients may "live well despite the pain" and be less reliant on repeated and costly hospital-based care, and findings may provide grounds for offering the intervention to our procedural patients more broadly.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134710 0
Dr Amelia Searle
Address 134710 0
C/O Flinders Medical Centre PMU, Flinders Drive, Bedford Park SA 5042
Country 134710 0
Australia
Phone 134710 0
+61 882044016
Fax 134710 0
Email 134710 0
[email protected]
Contact person for public queries
Name 134711 0
Dr. Porhan Kang
Address 134711 0
C/O Flinders Medical Centre PMU, Flinders Drive, Bedford Park SA 5042
Country 134711 0
Australia
Phone 134711 0
+61 882045499
Fax 134711 0
Email 134711 0
[email protected]
Contact person for scientific queries
Name 134712 0
Dr Amelia Searle
Address 134712 0
C/O Flinders Medical Centre PMU, Flinders Drive, Bedford Park SA 5042
Country 134712 0
Australia
Phone 134712 0
+61 882044016
Fax 134712 0
Email 134712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23892Study protocol  [email protected]
23893Informed consent form  [email protected]
23894Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.